Job DescriptionWe are currently seeking a Senior Manager of Regulatory Operations. Within the role you will:
- Develop and execute novel drug regulatory strategy
- Develop and manage day-to-day operations through the use of project management and planning tools, create and maintain detailed project timelines
- Establish sound regulatory advice/position on key development issues, and communicate same to the respective stakeholders
- Provide a high-level review of client programs and develop strategic plans for clinical, analytical, and process development
- Ensure development programs are compliant with ICH regulatory requirements and all local country regulatory requirements
- Initiate, author, and/or collaborate on SOP's, work instructions and Work Flows for the regulatory operations function. e.g. electronic Common Technical Document (eCTD) Investigational and Marketing Applications, and post-marketing compliance maintenance submissions in the United States, Europe, and RoW
- Author clear and concise regulatory documents (CMC authoring) with oversight of all documents for regulatory submissions and associated messaging
- Work closely with the development team to ensure overall regulatory strategy, regulatory CMC strategy, and labeling strategy for Pharmaceutical/Biological products are aligned
- Be the point of contact between the company and the regulatory agency - serve as the regulatory liaison
- Help strategize a road map for EU expansion: MAA planning (Type of submissions - DCP, CP, NP, MRP, Country(ies) selection for MAA and for being CMS vs. RMS and Inputs to set up EU QPPV Office
Desirable Skills and Experience - 10 - 15 years' experience working in a regulated, life science environment
- Strong project management skills
- Good interpersonal skills
- Business development skills
- Experience in defining organizational strategy, process and change management, KPIs and metrics, resource forecasting
- Extensive knowledge of global submission standards, including but not limited to FDA, HC, EMA, ICH, eCTD and industry trends for dossier preparation (IND/CTA/NDA/MAA/NDA) and regulatory change management and operations.
- Knowledge on RoW markets is a plus
- Experience in medical device regulations is a plus
- Knowledge of eCTD publishing systems, TRS toolbox, and related tools
- Sound understanding of regulatory information management concepts and tools needed to perform regulatory operations priorities in support of all business areas
